Y.E.S. POWERED WHEELCHAIR, MODEL T200
FDA 510(k) clearance K032669 · decided 2003-11-12
Clearance details
- K-number
- K032669
- Device name
- Y.E.S. POWERED WHEELCHAIR, MODEL T200
- Applicant
- Yeou Eir Shuen Machinery Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-28
- Decision date
- 2003-11-12
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- ITN
- Device class
- 1
- Regulation number
- 890.3675
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Hsin-Chu City, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIEWMATE SYSTEM (K071028) | Ep Medsystems | 2007-05-01 |
| COUNTER-ROTATION SYSTEM (K821256) | The Langer Group | 1982-06-23 |
Recalls involving this device
No recalls on record reference this clearance.